Wednesday, November 19, 2008

F.D.A. Medical Device Decision Making-Misconduct?

Yesterday, The New York Times published an article about the Food and Drug Administration's possible misconduct in its medical advisory review process. Breast implants are reviewed as medical devices and these allegations may possibly involve breast implants.

Here's an excerpt from the New York Times article:

"WASHINGTON — Top federal health officials engaged in “serious misconduct” by ignoring concerns of scientists at the Food and Drug Administration and approving for sale unsafe or ineffective medical devices, the scientists have written in a letter to Congress... The letter says that the scientists have documentary evidence that senior agency managers “corrupted the scientific review of medical devices” by ordering experts to change their opinions and conclusions in violation of the law."

Did the F.D.A. ignore scientists' opinions when it made its silicone breast implant approval decision in 2006?

Did senior F.D.A. management corrupt the process and violate the law?

Stay tuned into this story--if experts were coerced into changing their opinions regarding any medical device, this is very serious.

Read the New York Times Article in its entirety.

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